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EC number: 272-574-2 | CAS number: 68890-66-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted prior to GLP and although it was not done according to any recognised testing guideline it followed scientifically accepted standards at that time. Based hereupon it does meet many of the requirements of OECD Test Guideline 407. The study itself is also well conducted, well documented and scientifically acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Subacute (30-day) oral toxicity study via gavage in rats
- GLP compliance:
- no
- Remarks:
- but performance and documentation equivalent to GLP
- Limit test:
- no
Test material
- Reference substance name:
- Octopirox
- IUPAC Name:
- Octopirox
- Reference substance name:
- Piroctone olamine
- IUPAC Name:
- Piroctone olamine
- Reference substance name:
- 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)
- EC Number:
- 272-574-2
- EC Name:
- 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)
- Cas Number:
- 68890-66-4
- Molecular formula:
- C14H23NO2.C2H7NO
- IUPAC Name:
- 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)
- Reference substance name:
- 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt
- IUPAC Name:
- 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoe:WISKf SPF 71
- Age at study initiation:
- Weight at study initiation: 100 - 110 g
- Fasting period before study:
- Housing: plastic cages
- Diet (e.g. ad libitum): Altromin 1324
- Water (e.g. ad libitum):Tap water
- Acclimation period:8 hours
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: starch mucilage
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Justification for use and choice of vehicle (if other than water): starch mucilage
- Amount of vehicle (if gavage): 10 mL/kg - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 30 consecutive days
- Frequency of treatment:
- 1 treatment per day, 7 treatments per week for 30 consecutive days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
4 mg/kg body weight
Basis:
other: nominal in starch mucilage
- Remarks:
- Doses / Concentrations:
15 mg/kg body weight
Basis:
other: nominal in starch mucilage
- Remarks:
- Doses / Concentrations:
55 mg/kg body weight
Basis:
other: nominal in starch mucilage
- Remarks:
- Doses / Concentrations:
210 mg/kg body weight
Basis:
other: nominal in starch mucilage
- Remarks:
- Doses / Concentrations:
800 mg/kg body weight (control)
Basis:
other: starch mucilage
- No. of animals per sex per dose:
- 10 males and 10 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on acute toxicity data, expert judgement
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: no satellite group
- Post-exposure recovery period in satellite groups: no recovery group
- Section schedule rationale (if not random): random - Positive control:
- not required
Examinations
- Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: day 1, 3, 7, 10, 14, 17, 21, 24, 28, 30
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: before the beginning and at the end of the study
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 10 male and 10 female per dose-group
- Parameters examined: erythrocyte count, thrombocyte count, hematocrit, leucocyte count, hemoglobin, differential blood count, reticulocyte, methemoglobin
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: end of study
- Animals fasted: No
- How many animals: 10 male and 10 female per dose-group
- Parameters examined: bilirubin, SGOT, glucose, SGPT, urea-N, AP
URINALYSIS: Yes
- Time schedule for collection of urine: day before the first treatment and at the end of the study
- Metabolism cages used for collection of urine: No
- Animals fasted: No
- Parameters examined: appearence, pH, color, glucose, sediment, bilirubin, protein, hemoglobin
NEUROBEHAVIOURAL EXAMINATION: No
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER:- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Yes (Student t-tests; F-test; modified F-test)
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
There were no signs of toxic effects up to 55 mg/kg in male rats and up to 210 mg/kg in female rats. Except one male and one female of the highest dose-group all animals survived the treatment.
BODY WEIGHT AND WEIGHT GAIN
The body weights of the male rats which received 800 mg/kg were significantly decreased at the end of the study. The body weights of the male animals from the remaining dose-groups and those of the female of all dose-groups were in the same range than those of the controls.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
The male rats from the 210 mg/kg and 800 mg/kg group exhibited slightly increased relative food intake at the end of the study. A comparable effect was observed in females only at the highest dose-group.
FOOD EFFICIENCY
no data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study)
no data
OPHTHALMOSCOPIC EXAMINATION
no data
HAEMATOLOGY
The haematological investigation revealed a decrease of erythrocyte values, haemoglobin, haematocrit, and an increase in reticulocytes and thrombocytes in male and female rats of the highest dose group.
CLINICAL CHEMISTRY
No treatment related abnormalities observed.
URINALYSIS
No treatment related abnormalities observed.
NEUROBEHAVIOUR
no data
ORGAN WEIGHTS
No significant substance related differences between the relative organ weights of control and treated animals were observed up to the 210 mg/kg dose-group. A significant increase in organ weights of the highest dose group was seen for the heart, kidney and adrenals.
GROSS PATHOLOGY
Gross examination of the organs revealed no macroscopically visible changes.
HISTOPATHOLOGY: NON-NEOPLASTIC
Histopathology revealed no morphological organ changes up to 210 mg/kg. Partial damage to renal tubules was observed in three animals of the high dose group which was not considered to be treatment related.
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
No neoplastic findings were observed.
HISTORICAL CONTROL DATA (if applicable)
not included
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- >= 55 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Increase in relative food consumption
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOEL
- Effect level:
- >= 210 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: retarded body weight development, haematological changes
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the results obtained, the no toxic effect level of Octopirox was conservatively placed at 55 mg/kg body weight for males and at 210 mg/kg body weight for females.
- Executive summary:
In a 30 day study piroctone olamine was administered daily to groups of 10 male and 10 female rats via gastric-tube at dose levels of 0, 4, 15, 55, 210 or 800 mg/kg body weight. Except one female of the highest dose-group all animals survived the treatment. The cause of the death was not considered to be treatment related. An increase of relative food consumption was noticed in the male animals of 210 mg/kg dose-group and in the females of the 800 mg/kg dose group. In addition retardation of body weight gain could be observed in the male animals of the 800 mg/kg dose-group. The haematological investigation revealed a decrease of erythrocyte values, haemoglobin, haematocrit and an increase in reticulocytes and thrombocytes in males and females of the highest dose-group. The clinical chemistry and urinalysis did not show any treatment related abnormalities. Gross examination of the organs revealed no macroscopically visible changes. Although signs of a partial damage of kidney tubulli could be observed in the two intercurrent deceased animals and in one animal of the highest dose-group, these changes were not considered to be treatment related since these findings were not seen in a subchronic, 90 -day study in rats. Based on the results obtained, the no-toxic effect level (NOEL) of piroctone olamine was placed at 55 mg/kg body weight and 210 mg/kg body weight for male and female animals respectively.
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